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Growers Avoid Altered Alfalfa

By Anna King, Herald staff writer
Tri-City Herald
January 20, 2005

Jim Eckenberg said doesn't want anything to do with Roundup Ready alfalfa.

The Mattawa hay farmer puts up about 125,000 tons of alfalfa each year and exports most to Japan. And he says the Japanese "are scared to death" of genetically modified hay.

Hay exporters and growers discussed the new weed killer-proof hay Wednesday at the Washington State Hay Growers Association annual conference in Kennewick. Seed for the new crop could be released as early as fall, officials said.

Proponents of the new genetic engineering technology that produced alfalfa resistant to the popular weed killer Roundup say it could help farmers produce more hay at a lower cost.

But opponents say their Pacific Rim customers don't want it and that keeping genetically modified alfalfa separate from the rest of the crop could prove difficult.

Japan is by far the largest and most valuable export market for Mid-Columbia hay growers. This year Washington producers are expected to grow about 490,000 acres of alfalfa.

Eckenberg said he is concerned that bees could cross-pollinate Roundup Ready alfalfa with fields intended to be free of the new gene.

"The first couple of years they should be able to keep it clean, but afterwards this is going to become a problem," he said.

Eckenberg said if the Japanese would accept the new hay, he wouldn't have a problem growing it, although it also poses other problems.

For one thing, he said it might be difficult to kill Roundup Ready alfalfa and change crops. "Once you make a Roundup Ready alfalfa, what can you use to kill the plant?" he said.

Those working on the new varieties say release of Roundup Ready seed will be done with care, after markets have accepted it.

"We are looking for deregulation sometime mid-year," said Adrian Crance, a Spokane-based Monsanto representative.

Monsanto is well known for developing genetically altered corn and soybeans. Last year the company abandoned further development of its Roundup Ready wheat after seven years of work, partly because Japan and other countries didn't want the product.

Crance said alfalfa would be easier to control than wheat and that the two can't be compared. Hay is not mixed in storage to the extent that wheat is, and there are fewer acres of hay to regulate than wheat, he said.

Mark McCaslin, president of Forage Genetics which is developing the Roundup Ready alfalfa for Monsanto, said the new varieties have been tested in fields in eight locations from Washington to Pennsylvania.

He said scientists have developed about a dozen Roundup-resistant varieties that can compete with conventional alfalfa for disease resistance, yields and hardiness.

To grow the new alfalfa, producers will have to follow a protocol, he said. Rules would include a waiting period of three years between growing Roundup Ready alfalfa and conventional alfalfa, he said. That way alfalfa seeds, which can germinate a few years after being dropped off a plant, wouldn't mix with another alfalfa crop.

McCaslin said even if the Japanese government allows genetically altered alfalfa into the country, individual dairy farmers still may reject it. That problem could be solved by carefully separating and transporting hay, he said.

"They want to trace hay from the Columbia Basin to the user in Japan," he said.

A new test would check for the Roundup Ready gene in alfalfa, McCaslin said.

McCaslin said release of the new alfalfa would be done with care because it's the first of many genetically modified hay varieties that will be appearing on the market in the next few years. On deck are varieties that contain more protein and less indigestible fiber, he said.

Yet Mark Anderson, president of Anderson Hay and Grain -- one of the largest hay exporting companies in Washington -- said neither he, nor his customers, are ready for Roundup Ready alfalfa. "They don't want all the politics and problems that go with it."


Genetic Researchers Cite Specter Of Profits

by Lisa M. Krieger
San Jose Mercury News
February 17, 2000

Asilomar: Scientists say demands for financial gain threaten public health by concealing dangers.

PACIFIC GROVE -- The genetic-research pioneers who 25 years ago warned of public-health and environmental catastrophes if their science went awry are debating a new threat: rampant commercialization and carelessness.

A quarter-century after they first gathered at the rustic Asilomar retreat, these now-graying scientists have returned for a three-day conference. And they are warning that pressures on researchers to compete and on biotech firms to earn profits, while withholding information about their failures, are undermining a tradition of scientific integrity established at the original Asilomar Conference of 1975.

"The major thing we achieved (in 1975) was . . . public trust," said Paul Berg, who convened the original conference and is now director of the Beckman Center for Molecular and Genetic Medicine at Stanford University's School of Medicine. "This led to public acceptance of the belief that science was in reasonably responsible hands."

"In retrospect, very few . . . foresaw the pervasive, complex, robust and rich ramifications of recombinant DNA technology. Nor could most have predicted the pace at which fundamental understanding of biology has deepened," Berg said.

Dr. Donald S. Fredrickson, the former director of the National Institutes of Health, put it more harshly. "Morality has been soiled. Entrepreneurs are repressing any information that suggests an unfavorable outcome as `proprietary' -- and keep it secret," Fredrickson said. "We need a re-awakening -- a moral re-evaluation."

Although the three-day symposium will not result in a formal statement about current issues, it has triggered heated debate about a world of biology that has profoundly changed in 25 years.

Biotech has grown from a field dominated by academic researchers to one driven by companies with millions of dollars at stake. The industry has developed a wide array of life-saving therapies.

But there is growing tension between the tradition of openness and the demand for greater privacy by commercial biotech companies, according to the 50 participants from throughout the United States and several other countries.

This tension boiled to the surface in September when Jesse Gelsinger, 18, died of complications of gene therapy at University of Pennsylvania. The incident increased public concern about whether scientists could be trusted.

Experimental therapy

Gelsinger had been undergoing experimental gene therapy developed at the Institute for Human Gene Therapy at the University of Pennsylvania. The institute was directed by James M. Wilson and was financed partially by a biotech company that Wilson founded -- an arrangement that has drawn the interest of government investigators. The university has admitted mistakes and administrative lapses but denies liability for the death.

Since the incident, medical centers have reported to the NIH 691 cases of serious adverse effects in gene therapy experiments, the agency disclosed last week. Many of these reports, required by law, were delayed weeks, even months.

A review by Rep. Henry Waxman, D-Los Angeles, found that 652 of the 691 cases were reported late; fewer than 6 percent were filed on time. Moreover, at least some of the previously unreported deaths remained unexplained, raising the possibility that Gelsinger was not the first to be killed by gene therapy complications.

The prestigious Pennsylvania gene research program has since been charged with "numerous serious deficiencies." That disciplinary action follows similar transgressions, although no deaths, at Duke University, the Los Angeles Veterans Administration Hospital, the University of Illinois at Chicago, the University of Alabama-Birmingham, the University of Colorado Health Sciences Center and Virginia Commonwealth University.

Genetic research is going through a significant transition, said the scientists at Asilomar, where they once met to ponder the risks of a gene-splicing technique that has now become routine.

In 1974 -- long before the ethical quagmire of human cloning, embryo research and other technologies now on the horizon -- they were so jittery about the impact of their science that they called for a self-imposed moratorium on some research.

The Asilomar agreement, brokered by leading molecular geneticists such as NIH's Maxine Singer and Stanford's Berg, marked the first time that any major branch of science had voluntary suspended its work.

In the early years, almost all research was federally funded, with expectations of open disclosure of results and research plans. The scientists held the moral reins, creating a tough advisory committee to oversee research.

"In recent years, there has been a shift away from the culture of civic mindedness to greater individualism," said Parris Burd, director of regulatory affairs for the Redwood City-based biotech firm Maxygen. "We need to educate our young scientists of their civic responsibilities and obligation to participate (in the public review process)."

Now debate rages over whether scientists should be required to report biotech research failures to the NIH, which can disclose them to the public, in addition to the Food and Drug Administration, which keeps such information confidential.

Regulatory changes

The Biotechnology Industry Organization is seeking regulatory changes that could decrease public reporting of adverse events the organization considers proprietary.

But consumer advocates such as Dr. Peter Lurie of Public Citizen's Health Research Group in Washington, D.C., say "one cannot conduct quality or ethical research in an environment in which other scientists' experiences are hidden. Denying information can be hazardous; this may be the real lesson of the Gelsinger episode."

"We did not foresee the emergence of venture capital . . . and researchers who invest in and oversell the promise (of their research) and keep adverse effects quiet . . . and who advance their careers with little time spent on long-term thinking," said Singer, then a research biochemist at the NIH and now president of the Carnegie Institute in Washington, D.C.

"While this creates exciting and constructive competition," Singer said, "some scientists have compromised their behavior."


Asilomar Revisited: Lessons for Today?

by Marcia Barinaga
American Association for the Advancement of Science
March, 2000

A conference last month asked whether the "Asilomar process" could help to resolve today's biotech controversies

PACIFIC GROVE, CALIFORNIA--The Asilomar conference on recombinant DNA was the Woodstock of molecular biology: a defining moment for a generation, an unforgettable experience, a milestone in the history of science and society. But was it something that could--or even should--be repeated?

Those were some of the questions on the minds of 55 scientists, lawyers, historians, and ethicists who gathered here last month at the Asilomar Conference Center near Monterey to mark the 25th anniversary of that historic meeting. In February 1975, 140 participants--mostly biologists, with a handful of lawyers and physicians and 16 members of the press--gathered at the rustic conference center overlooking the Pacific to tussle with an issue that had just burst onto the biology scene: the safety of recombinant DNA research. Known officially as the International Congress on Recombinant DNA Molecules but remembered ever since simply as "Asilomar," that meeting was widely hailed as a landmark of social responsibility and self-governance by scientists. The participants in last month's conference*--who included 11 of the 1975 conferees--were not just here to reminisce. Legal scholar Alex Capron, a participant in the 1975 meeting and now co-director of the Pacific Center for Health Policy and Ethics at the University of Southern California in Los Angeles, assembled the group to discuss what lessons could be learned from the "Asilomar process" and, specifically, whether there are situations today in which it might be appropriately applied.

Asilomar occurred at a unique moment in biology. Researchers had just discovered how to cut and splice together the DNA of disparate species and were beginning to contemplate the cornucopia of experiments this opened up. "Recombinant DNA was the most monumental power ever handed to us," said California Institute of Technology president David Baltimore, one of the organizers of the 1975 meeting. "The moment you heard you could do this, the imagination went wild." But a number of scientists at the time raised concerns about whether such experiments might create dangerous new organisms, microscopic Frankensteins that could sneak out of the lab undetected on the sole of a Hush Puppy and threaten public health.

Those concerns triggered a "hectic experience" of scientific soul-searching that culminated in the 1975 Asilomar conference, recalled Stanford molecular biologist Paul Berg, another organizer of that meeting. Participants at a June 1973 Gordon Conference on Nucleic Acids had published a letter expressing concern about recombinant DNA research. In response, Berg led a committee of the National Academy of Sciences that in July 1974 took the unusual move of calling for a voluntary moratorium on certain types of recombinant DNA experiments until the hazards could be evaluated.

Berg and several colleagues organized the Asilomar meeting 7 months later to bring together "people who were engaged in the research or were likely or eager to use it." The organizers also brought in researchers with expertise in bacteria and viruses to help assess the potential hazards. A sense of urgency pervaded the meeting, in part because researchers were impatient to put the new technology to work. Although most of the participants suspected that there was no real hazard, Baltimore said, the stakes were clearly "too important to be wrong." The meeting's organizers decided not to address the ethical issues surrounding genetic alteration but to stick to safety issues they felt they could address as scientists. After much haggling, the group settled on a set of safety guidelines that involved working with disabled bacteria that could not survive outside the lab. The guidelines not only allowed the research to resume but also helped persuade Congress that legislative restrictions were not needed--that scientists could govern themselves.

The group that convened last month faced a very different set of circumstances. The technology that seemed like science fiction in 1975 is now commonplace and has yielded what Baltimore called "a remarkable harvest" of products and applications, such as genetically enhanced crops, tests for genetic diseases, and human gene therapy. Last month's meeting also had less of a sense of urgency because, for the most part, scientists consider these technologies safe.

But the public remains hugely concerned about the applications of genetic manipulation: Witness the recent protests in Europe over genetically modified crops. And society today is much more insistent on participating in the debate. "There are no important risks that scientists alone can assess," said Princeton University president Harold Shapiro, chair of the National Bioethics Advisory Commission. "Scientists can make a great contribution, but they can't decide alone."

What's more, the scientists themselves have changed. Those who gathered at Asilomar in 1975 represented a research community that was purely academic in its interests. Today, "there are few pure academics left" in molecular biology, Baltimore noted. As genetic engineering has gone commercial, academics have followed, and today most senior academic researchers have ties to biotechnology companies that would complicate any attempts at self-scrutiny.

During the course of last month's 2-day meeting, participants concluded that, for these and other reasons, it would not be appropriate now for scientists alone to take on the task of analyzing the risks of their work while setting aside the ethical issues, as they did a quarter-century ago at Asilomar. Nevertheless, as they debated the genetic modification of crops, gene therapy, and the use of genomic information, the participants identified instances in which society might have benefited if scientists had actively contributed to a public debate about the safety of their work.

One of those was gene therapy, the subject of the most intense soul-searching at the meeting. Gene therapy has been in the hot seat since the death last September of Jesse Gelsinger, an 18-year-old subject in a gene-therapy trial at the University of Pennsylvania. Others in the field knew that the adenovirus vectors being used in the Pennsylvania trial could cause potentially dangerous immune reactions, like the one that apparently killed Gelsinger, said gene therapy researcher Inder Verma of the Salk Institute in La Jolla, California. "Why didn't we stand up" at meetings and raise those concerns? Verma asked.

Picking up on Verma's remark, Baltimore urged that "it is absolutely necessary" for gene therapists to slow down and reexamine the standards for when to begin trials on human subjects. "There are times when some things shouldn't happen," he said. Gene therapy vectors "that weren't working in animals are going into humans. A lot of us are saying what the hell are [doctors] doing putting these into people?" The Gelsinger death and the publicity it has generated are sure to raise public suspicion, said Maxine Singer, president of the Carnegie Institution of Washington: "It will be difficult to repair the damage that has already been done to biomedical research and gene therapy research."

Some participants also suggested that the huge public backlash against genetically engineered crops might have been averted if scientists, both commercial and academic, had taken a more active role in analyzing risks--not only as they perceived them but also as society was likely to--and perhaps exercised restraint until those uncertainties could be resolved. What made Asilomar unique was that the scientists "gave other people's perspectives some standing," said Shapiro. "Here is a case where commercial interests are suffering a great deal from not having confronted these problems in this way."

But with substantial U.S. acreage--for example, one-third of the corn and half of the cotton and soybeans--planted with genetically modified crops, it is too late to go back to a scientist-controlled process of self-regulation, said Rebecca Goldberg of New York City-based Environmental Defense. Indeed, it is naive to think that any controversial issue can, or should, be resolved by scientists alone, said sociologist Dorothy Nelkin of New York University. She pointed out that public fears about the safety of new genetic technologies often mask deeper societal concerns. In the case of genetically modified crops, for example, "when the French talk about risk, they are talking about McDonald-ization of France and the plight of the small farmer. When the British talk about risk, they are worrying about the alteration of nature. Even if it could be demonstrated that the risks were acceptable, the controversy would continue."

Although it may be too late to influence the debate on genetically modified foods, at least some of the conferees thought an updated Asilomar-like analysis of scientific risks could still make an important contribution in two areas: germ line engineering and xenotransplantation. Gene therapy that alters germ line cells is an ethical minefield, as such alterations would be transmitted to future generations. "At Asilomar [in 1975], people said they would draw the line at germ line gene therapy," said science historian Charles Weiner of the Massachusetts Institute of Technology (MIT). Now, although germ line therapy in humans is not actually being done, "it's on the table" as an option, said Weiner. Weiner and others worry that techniques developed to correct genetic diseases may eventually be used to engineer desired traits into children.

In addition to those ethical concerns, the group debated scientific risks. Geneticist Arno Motulsky of the University of Washington, Seattle, argued that germ line therapy could "lead to reduction of genetic disease" and so should not be dismissed out of hand. But physician and geneticist Paul Billings, co-founder of GeneSage, a San Francisco Internet-based genetic information and health company, countered that germ line therapy is not necessary, given other options such as prenatal or preimplantation diagnosis of genetic defects. What's more, he said, the altered genes, especially if they insert randomly into the germ line genome, may have unpredictable and potentially very subtle negative effects on health or intelligence. Although difficult to detect, such effects could be "quite significant" to individuals and their descendents, said Billings. To MIT molecular biologist Phillip Sharp, debate such as this emphasizes the need for an Asilomar-like "attempt at evaluation and consensus in the scientific community" concerning germ line therapy.

As for xenotransplantation, the transfer of organs from nonhuman species into humans, there are concerns that the procedure could endanger public health by transferring animal viruses to humans. Other countries are considering or have instituted moratoria on the procedure, said Lana Skirboll, director of the Office of Science Policy at the U.S. National Institutes of Health, but the United States has done nothing. "We need a scientific assessment," she said.

At the end of last month's meeting, Berg reflected on the differences between 1975 and 2000 and what they might mean for the resolution of scientific controversies. One factor that made the first meeting work, he said, was the "suddenness of the issue." Because molecular biologists weren't yet heavily invested in recombinant DNA technology and the public knew little about it, "it was much easier to get people to agree on a course of action," Berg told Science. Most of the issues discussed at last month's conference are "chronic," he noted. And "once an issue becomes chronic, positions become hardened, and consensus is much more difficult to achieve." What's more, Berg and others noted that consensus might never have been reached if the scientists at Asilomar had not agreed to put aside the ethical issues and stick to biological hazards. In 1975, that process worked, and the research not only went on safely but won the public trust. Today "we are in a very different world," said philosopher Stephen Stich of Rutgers University in New Brunswick, New Jersey, where that public trust is not so easily won.

But that in no way diminishes the need for scientists to reflect on the impact of their work on society, said Susan Wolf, a professor of law and medicine at the University of Minnesota, Minneapolis. What was unique about Asilomar was that "a group of scientists was convened to reflect upon how their work affected other people's lives ," said Princeton's Shapiro. And that, he and others agreed, is something that scientists owe society as they move toward whatever the next scientific revolutions might be.

* Symposium on Science, Ethics, and Society:
The 25th Anniversary of the Asilomar Conference, 15-17 February 2000.

Scientific Community Volume 287, Number 5458 Issue of 3 Mar 2000, pp. 1584-1585
The American Association for the Advancement of Science.
Copyright © 2000 by the American Association for the Advancement of Science.


Hungary Bans Monsanto GMO Maize Seeds

by David Chance
January 20, 2005

BUDAPEST, January 20, 2005 - Hungary, one of the biggest grain producers in the new EU, became the first country in eastern Europe to ban GMO maize when on Wednesday it outlawed the planting of Monsanto Co's MON 810 maize hybrid seeds. The Agriculture Ministry said it had banned MON 810 maize seed planting pending tests to establish whether GM crops contaminate other crops and said old stocks must be destroyed, although it will continue to allow GMO maize in food production.

"The temporary measure bans the production, use, distribution and import of hybrids...deriving from the MON 810 maize line," the ministry said in a statement.

MON 810 is allowed in the European Union, but individual countries currently have discretion over whether to allow it and other gene-altered crops.

No GMO crops are grown in Hungary at present and the Hungarian ban on MON 810 will come into force on Thursday and remain until tests are completed.

Anti-GMO campaigners say the technology is not proven and that it could contaminate other crops, while the industry says it vastly benefits consumers and there is no evidence of contamination from numerous trials of the crops.

Monsanto said two maize variants based on MON 810 had been awaiting approval in Hungary and that the ban was not justified, adding that Hungary had made a unilateral decision and did not appear to have consulted the European Commission.

Brussels-based Monsanto spokesman Daniel Rahier said the company did not believe that the issue of the co-existence of GMO and non-GMO crops could be used to justify a ban.

"The ban was a great disappointment for us, there was no condition which required this action, no one wanted to import genetically modified corn seed into Hungary," said Mihaly Czepo, who deals with biotechnology issues for the company in Hungary.

The ministry said the Monsanto hybrid will still be allowed to ship across Hungary, although packages must not be opened, nor the seed modified in any way, the ministry said.

"The ban applies to seed producers and distributors as well as farmers," the ministry said.

Hungary is a major grains producer and had a bumper harvest in 2004 of 16.7 million tonnes of grain, up 90.5 percent on the previous year, and much of that is exported to the European Union.

Maize output alone was 8.3 million tonnes in 2004.

Austria, France, Germany, Greece and Luxembourg have bans on particular products -- three GMO maize varieties and two types of rapeseed.

Opponents of the technology have expressed concern that the new European Union countries, many of them relatively poor ex-communist countries, could provide a back door for GMO food production, something the industry has denied.

Poland allows the import of GMO maize and is in the process of passing a law which would allow for growing of GMO maize in Poland, which is expected to be voted on in parliament this year.

Romania, also a big grains producer which hopes to join the EU in 2007, allows genetically modified soya and is keen to expand GMO food production.

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